In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney, and if you’re a dietary supplement brand owner, this one’s for you.
FDA compliance for supplements can seem overwhelming, but it really comes down to four pillars.
First, cGMP compliance. Your manufacturing facility must operate under Current Good Manufacturing Practices — 21 CFR Part 111. This covers everything from testing and quality control to record-keeping and personnel training.
Second, labeling. Your Supplement Facts panel, ingredient list, net quantity, and any claims on your label must comply with FDA regulations. One labeling error can result in your product being considered misbranded.
Third, facility registration and product listing. Domestic and foreign facilities that manufacture, process, pack, or hold dietary supplements must be registered with the FDA and renewed every two years during October through December.
Fourth, claims compliance. Make sure any claims you make — on the label, on your website, or on social media — are properly substantiated and include the required disclaimers for structure/function claims.
These four pillars form the foundation of supplement compliance. Get these right, and you’re in a much stronger position. We help supplement brands build that foundation. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.